Assessing the Efficacy of Probiotics in Prevention of NEC in Preterm Babies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, 10% dextrose.
- Who it may be relevant to
- Registry conditions: NEC, NEC - Necrotizing Enterocolitis. Basic parameters: up to 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not.
Detailed description
: In the last five years, many systematic reviews have shown the benefit of Probiotics in prevention of NEC and Sepsis in preterm babies but most of these studies have been done in the developed countries. Although the overall benefit has been tilted In favor of use of probiotic however a definitive consensus has not been reached due to inconsistencies in results. Moreover, the impact of multistrain probiotics in our particular population has not been studied, which provides the rationale for our research
Interventions
- Drug Probiotic
All preterm babies \<34 weeks Gestational age admitted within 24 hrs of life will be eligible for the study. Those full filling inclusion criteria and consenting to participate will be recruited. Consent will be obtained by team not caring for the patient. Each recruited patient will be assigned a case ID number. Based on the Randomization babies will be assigned to either the intervention group or control group. Study group: Multistrain probiotic containing a mix of Lactobacillus and Bifidobac - Drug 10% dextrose
This will receive 10% DW as placebo
Primary outcome measures
- Number of participants who develop NEC on probiotic vs placebo [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- Male and female preterm infants with a gestational age less than 35 weeks.
- All indoor patients and outdoor patients who present within 24hrs of birth
Exclusion criteria
- • Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis.
- Infants with severe sepsis or gastrointestinal bleeding on presentation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Pammi M, Cope J, Tarr PI, Warner BB, Morrow AL, Mai V, Gregory KE, Kroll JS, McMurtry V, Ferris MJ, Engstrand L, Lilja HE, Hollister EB, Versalovic J, Neu J. Intestinal dysbiosis in preterm infants preceding necrotizing enterocolitis: a systematic review and meta-analysis. Microbiome. 2017 Mar 9;5(1):31. doi: 10.1186/s40168-017-0248-8. PMID 28274256
Identifiers
NCT: NCT07233382 · ERB # 2731 · Agha Khan